| CTRI Number |
CTRI/2025/09/095489 [Registered on: 30/09/2025] Trial Registered Prospectively |
| Last Modified On: |
29/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Fumigation (Neem leaves, Vacha, Hingu, Lavan, Sarshap, Ghruta) And Jatyadi Oil Dressing For Wound Care. |
|
Scientific Title of Study
|
A Comparative Clinical Evaluation Of Nimbapatradi Dhoopana And Jatyadi Taila Dressing In Dushta Vrana. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rina Gupta |
| Designation |
PG Scholar |
| Affiliation |
Quadra Institute Of Ayurveda |
| Address |
OPD No-1 Department Of Shalya Tantra Quadra Institute Of Ayurveda And Hospital NH58 Roorkee Haridwar Road Near Montfort School. Roorkee
Hardwar
UTTARANCHAL
247667
India |
| Phone |
06280366653 |
| Fax |
|
| Email |
rinagupta264@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranjit Singh Manhas |
| Designation |
Professor |
| Affiliation |
Quadra Institute Of Ayurveda |
| Address |
OPD No-1 Department Of Shalya Tantra Quadra Institute Of Ayurveda And Hospital NH58 Roorkee Haridwar Road Near Montfort School. Roorkee
Hardwar
UTTARANCHAL
247667
India |
| Phone |
06280366653 |
| Fax |
|
| Email |
dr.raji83@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Rina Gupta |
| Designation |
PG Scholar |
| Affiliation |
Quadra Institute Of Ayurveda |
| Address |
OPD No-1 Department Of Shalya Tantra Quadra Institute Of Ayurveda And Hospital NH58 Roorkee Haridwar Road Near Montfort School. Roorkee
Hardwar
UTTARANCHAL
247667
India |
| Phone |
06280366653 |
| Fax |
|
| Email |
rinagupta264@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rina Gupta Department Of Shalya Tantra Quadra Institute Of Ayurveda And Hospital.NH58 Roorkee Haridwar Road. 247667 |
|
|
Primary Sponsor
|
| Name |
Rina Gupta |
| Address |
Department Of Shalya Tantra Quadra Institute Of Ayurveda And Hospital NH58 Roorkee Haridwar Road. Near Montfort School 247667 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rina Gupta |
Quadra Institute Of Ayurveda And Hospital |
OPD No-1 Department Of Shalya Tantra Quadra Institute Of Ayurveda And Hospital NH58 Haridwar Near Montfort School Roorkee 247667
Hardwar
UTTARANCHAL |
6280366653
rinagupta264@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Quadra Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | vraNadhUpanam, व्रणधूपनम् | (Procedure Reference: Bhaishajya Ratnawali 47/50, Procedure details: 1. The Wound area will be cleaned gently to remove any debris, dirt, or old dressing. 2. Sufficient amount of the Nimbapatradi Churna will be mixed with Gomayachurna & Ghrita. 3. Above mixture will be placed on specially design Dhoopan Yantra, after lightening the mixture Yantra will be held near the Wound where the medicated smoke can effectively reach the open Wound. 4. Allow the smoke to come into cantact with the wound. Perform the fumigation process for 15-20 minutes, one time a day & dressing with Jatyadi Taila will be done. )
| | 2 | Comparator Arm | Procedure | - | tailam, तैलम् | (Procedure Reference: Sharangdhar Samhita, Madhyamkhanda,9/168-170, Procedure details: 1. The Wound will be cleaned with sterile water & pat it dry with a sterile guaze. Sterile gauze soaked in Jatyadi Taila place over the wound, covering the entire affected area. Then place a sterile dressing or bandage over the guaze pad to secure it in place. Replace the dressing daily & regularly inspect the Wound for any sign of healing, such as reduced inflammation, improved tissue repair, & decrease pain.)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Classical signs and symptoms of Dushta Vrana irrespective of their age, sex, occupation.
2 Patient between the age group of 20-70 years.
3 Patient voluntary willing to participate in the clinical trial.
|
|
| ExclusionCriteria |
| Details |
1 Patients of uncontrolled DM and HTN.
2 Patient with any systemic disorder.
3 Patient with any Anatomical abnormalities.
4 Pregnant and Lactating mothers
5 HIV/HCV/HBsAG positive patient. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
SUBJECTIVE
The assessment of trial will be done based on improvement in the symptoms mentioned as-
1- Vedana (Pain)
2- Daha (Burning Sensation)
3- Kandu (Itching) |
Assessment will be carried out on intermittent days of 4 week i.e. on 0th, 7th, 14th, 21st, 28th day to find out the efficacy of Dhoopan Karma with Jatyadi Taila dressing And only Jatyadi Taila dressing in Dushta Vrana. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Objective
1) Tenderness
2) Putipuya(Foul Smell)
3) Shopha Pidika(Granulation)
4) Size
5) Colour
6) Puyashrava(Discharge) |
Assessment will be carried out on intermittent days of 4 week i.e. on 0th, 7th, 14th, 21st, 28th day to find out the efficacy of Dhoopan Karma with Jatyadi Taila dressing And only Jatyadi Taila dressing in Dushta Vrana.
1st follow up-15 days after completion of treatment.
2nd follow up- 15 days after 1st follow up |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a comparative clinical study to find out the efficacy of Dhoopan Karma with Jatyadi Taila dressing in comparision to only Jatyadi Taila dressing as Jatyadi Taila is already established treatment in the Dushta Vrana, Dagdha Vrana, Sadhyo Vrana and to evaluate the efficacy of Dhoopan Karma with Jatyadi Taila dressing and only Jatyadi taila dressing in Dushta Vrana treatment. For the present research study total 40 patients are selected for clinical trial. In this clinical study, Dhoopan Karma with Jatyadi Taila dressing and only Jatyadi taila dressing will be done on 20-20 patients respectively. Patient will randomly selected with clinical features of Dushta Vrana attending the OPD and IPD of Shalya Tantra dept. and other dept. of Quadra Hospital irrespective of their gender, race, religion, occupation. This clinical study will be conducted with aim and objective to provide better, safe and effective management to the patient of Dushta Vrana. A detailed performa will be prepared on the basis of Ayurvedic text and allied Sciences. The patient fulfilling the inclusion and exclusion criteria will be registered on this performa and scoring of the different clinical features will be done on the assessment criteria. The observation of the patients will be done before, during and the after completion of trial. Little addition or exclusion may be done as per the necessity of the study. |